Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1

Zhejiang University

Status and phase: Withdrawn; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Oxaliplatin; Drug: Sorafenib; Drug: S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT02129322

ZYYYMedOncoLT01

Details and patient eligibility

About

The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hepatocellular carcinoma after liver transplantation
• Major organ (heart, lung and brain) function was normal

Exclusion criteria

• Any active infectious process
• The presence of clinically confirmed extrahepatic metastasis
• Postoperative dysfunction of any organ

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Sorafenib

Active Comparator group

Description:

Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance

Treatment:

Drug: Sorafenib

Drug: Oxaliplatin

Drug: S-1

S-1 and Sorafenib

Experimental group

Description:

Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance

Treatment:

Drug: Sorafenib

Drug: Oxaliplatin

Drug: S-1